UveitisNCT01859299
Intestinal Bacteria and Ocular Inflammatory Disease
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Uveitis
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2013to 29 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 participants: 150 with uveitis; 50 healthy controls
Who may be able to join
- Participant must be 18 years of age or older.
- Participant must have a diagnosis of:
- Uveitis (or ocular inflammatory disorder)
- Participant must be able to undergo slit lamp biomicroscopy.
- Participant must understand and sign the protocol s informed consent document.
- Participant must be 18 years of age or older.
Show all 9Show fewer
- Participant must be able to undergo slit lamp biomicroscopy.
- Healthy controls will be age-and sex-matched individuals with no personal history of uveitis or other rheumatologic/autoimmune diseases (such as arthritis, inflammatory bowel disease, type 1 diabetes mellitus, psoriasis, Sjorgren s syndrome or multiple sclerosis) and no current use of corticosteroids, disease modifying antirheumatic drugs (DMARDs) including those with antibiotic properties (e.g., gold salts, sulfasalazine, hydroxychloroquine, minocycline) or any immunomodulatory drugs.
- Participant must understand and sign the protocol s informed consent document.
Who cannot join
- Participants who are unable to provide informed consent.
- Recent (<3 months prior) use of any antibiotic therapy
- Current consumption of probiotics
- Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
- Known gastrointestinal (GI) tract neoplasm
- Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis) within the last month
Show all 21Show fewer
- Chronic unexplained diarrhea
- Participant has or had a significant active infection (an infection requiring treatment as determined by the investigator) that required systemic antibiotic treatment within the past three months
- Participant has any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)
- Participant has inflammatory bowel disease (IBD)
- Participant is pregnant or lactating.
- Recent (<3 months prior) use of any antibiotic therapy
- Current consumption of probiotics
- Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
- Known gastrointestinal (GI) tract neoplasm
- Recent GI tract infection (gastroenteritis, colitis, diverticulitis, appendicitis) within the last month
- Chronic unexplained diarrhea
- Participant has or had a significant active infection (an infection requiring treatment as determined by the investigator) that required systemic antibiotic treatment within the past three months
- Participant has any GI tract surgery leaving permanent residua (e.g., gastrectomy; bariatric surgery; colectomy)
- Participant has inflammatory bowel disease (IBD)
- Participant is pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Microbiome and Ocular Inflammatory Disease
Background:
- Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. They will study the natural bacteria present in the gut and intestines of people with and without uveitis to understand their potential role in these diseases.
Read more
Objectives:
- To study the intestinal bacteria in people with and without uveitis or ocular inflammatory disease.
Eligibility:
- Individuals at least 18 years of age who have uveitis or ocular inflammatory disease.
- Individuals at least 18 years of age without uveitis or ocular inflammatory disease to serve as healthy controls.
Design:
- Participants may have more than one study visit (approximately 2-4) to assess possible changes in microbiome composition associated with treatment or disease activity.
- At each visit, participants will have a full eye examination, including vision and eye pressure tests. They will provide blood samples for testing. Participants will also be provided a stool collection kit to take home. The samples may be sent or brought back to the clinic.
- Treatment will not be provided as part of this study.
Read the detailed description
Objective: What precipitates ocular inflammatory episodes remains unknown, but a possible potentiating factor is the microbiome. The microbiome has become increasingly studied with the advent of new techniques, but these have not been applied to uveitis. We wish to evaluate microbiome composition in patients with the ocular inflammatory diseases uveitis who may be on standard therapy or receiving orally-administered tolerizing antigen therapy.
Study Population: A total of 200 participants may be enrolled in this study. Of those participants, the goal is to enroll 50 healthy controls and 150 with various types of uveitis.
Design: This is an observational, prospective, single-center study. Participants will receive a complete ocular examination with clinical testing as determined clinically and will provide stool and blood samples using a standardized method. Participants may have multiple visits and may provide multiple samples in order to evaluate changes in microbiota composition with disease status or treatment.
Outcome Measures: Alterations in bacterial diversity, microbiota composition and changes in relative abundance of various taxa or species will be analyzed between healthy volunteers and participants and between various types of uveitis. In addition, comparisons will be made between these findings and the immunome and metabolome.
- Conditions
- Uveitis
- Keywords
- Oral Tolerance, Uveitis, AMD, Natural History
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Affected | Participants with various types of uveitis | |
| Healthy controls | Participants without uveitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html).
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html).
Measured: ongoing
Secondary outcomes (3)
Abundance differences between groups at the level of individual phylotypes
Abundance differences between groups at the level of individual phylotypes (at different taxonomic levels, from phylum to species); the significance between groups will be tested using ANOVA
Measured: ongoing
Abundance of microbial modules
abundance of microbial modules, constructed from microbial abundance co-occurrence networks and weighted gene co-expression network analysis (WGCNA) methodology, using the module eigenvector as the quantitative metric and statistically tested by ANOVA
Measured: ongoing
Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results
Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study start27 Aug 2013
- Primary completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily Y Chew, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859299
- Sponsor's protocol ID
- 130072
- Other IDs
- 13-EI-0072
- Status last verified
- 11 Sep 2026
- First submitted
- 17 May 2013
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nussenblatt RB, Gery I, Weiner HL, Ferris FL, Shiloach J, Remaley N, Perry C, Caspi RR, Hafler DA, Foster CS, Whitcup SM. Treatment of uveitis by oral administration of retinal antigens: results of a phase I/II randomized masked trial. Am J Ophthalmol. 1997 May;123(5):583-92. doi: 10.1016/s0002-9394(14)71070-0.
PubMed 9152063Presley LL, Ye J, Li X, Leblanc J, Zhang Z, Ruegger PM, Allard J, McGovern D, Ippoliti A, Roth B, Cui X, Jeske DR, Elashoff D, Goodglick L, Braun J, Borneman J. Host-microbe relationships in inflammatory bowel disease detected by bacterial and metaproteomic analysis of the mucosal-luminal interface. Inflamm Bowel Dis. 2012 Mar;18(3):409-17. doi: 10.1002/ibd.21793. Epub 2011 Jun 22.
PubMed 21698720Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Lozupone CA, Turnbaugh PJ, Fierer N, Knight R. Global patterns of 16S rRNA diversity at a depth of millions of sequences per sample. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4516-22. doi: 10.1073/pnas.1000080107. Epub 2010 Jun 3.
PubMed 20534432
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Ocular Inflammatory Disease
- ClinicalTrials.gov ID
- NCT01859299
- Acronym / sponsor ID
- 130072
- Conditions
- Uveitis
- Keywords
- Oral Tolerance, Uveitis, AMD, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. They will study the natural bacteria present in the gut and intestines of people with and without uveitis to understand their potential role in these diseases.
Objectives:
- To study the intestinal bacteria in people with and without uveitis or ocular inflammatory disease.
Eligibility:
- Individuals at least 18 years of age who have uveitis or ocular inflammatory disease.
- Individuals at least 18 years of age without uveitis or ocular inflammatory disease to serve as healthy controls.
Design:
- Participants may have more than one study visit (approximately 2-4) to assess possible changes in microbiome composition associated with treatment or disease activity.
- At each visit, participants will have a full eye examination, including vision and eye pressure tests. They will provide blood samples for testing. Participants will also be provided a stool collection kit to take home. The samples may be sent or brought back to the clinic.
- Treatment will not be provided as part of this study.
Detailed description
Objective: What precipitates ocular inflammatory episodes remains unknown, but a possible potentiating factor is the microbiome. The microbiome has become increasingly studied with the advent of new techniques, but these have not been applied to uveitis. We wish to evaluate microbiome composition in patients with the ocular inflammatory diseases uveitis who may be on standard therapy or receiving orally-administered tolerizing antigen therapy.
Study Population: A total of 200 participants may be enrolled in this study. Of those participants, the goal is to enroll 50 healthy controls and 150 with various types of uveitis.
Design: This is an observational, prospective, single-center study. Participants will receive a complete ocular examination with clinical testing as determined clinically and will provide stool and blood samples using a standardized method. Participants may have multiple visits and may provide multiple samples in order to evaluate changes in microbiota composition with disease status or treatment.
Outcome Measures: Alterations in bacterial diversity, microbiota composition and changes in relative abundance of various taxa or species will be analyzed between healthy volunteers and participants and between various types of uveitis. In addition, comparisons will be made between these findings and the immunome and metabolome.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected | – | –Participants with various types of uveitis |
| Healthy controls | – | –Participants without uveitis |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 participants: 150 with uveitis; 50 healthy controls
Key inclusion criteria (9 listed)
- Participant must be 18 years of age or older.
- Participant must have a diagnosis of:
- Uveitis (or ocular inflammatory disorder)
- Participant must be able to undergo slit lamp biomicroscopy.
- Participant must understand and sign the protocol s informed consent document.
Key exclusion criteria (21 listed)
- Participants who are unable to provide informed consent.
- Recent (<3 months prior) use of any antibiotic therapy
- Current consumption of probiotics
- Current extreme diet (parenteral nutrition, macrobiotic diet, etc.)
- Known gastrointestinal (GI) tract neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html).
Time frame: ongoing
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html).
3 secondary outcomes
Abundance differences between groups at the level of individual phylotypes
Time frame: ongoing
Abundance of microbial modules
Time frame: ongoing
Differences in lymphocyte and monocyte activation by different bacterial populations from the human microbiome results
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 9152063Nussenblatt RB, Gery I, Weiner HL, Ferris FL, Shiloach J, Remaley N, Perry C, Caspi RR, Hafler DA, Foster CS, Whitcup SM. Treatment of uveitis by oral administration of retinal antigens: results of a phase I/II randomized masked trial. Am J Ophthalmol. 1997 May;123(5):583-92. doi: 10.1016/s0002-9394(14)71070-0.
- Background: PubMed 21698720Presley LL, Ye J, Li X, Leblanc J, Zhang Z, Ruegger PM, Allard J, McGovern D, Ippoliti A, Roth B, Cui X, Jeske DR, Elashoff D, Goodglick L, Braun J, Borneman J. Host-microbe relationships in inflammatory bowel disease detected by bacterial and metaproteomic analysis of the mucosal-luminal interface. Inflamm Bowel Dis. 2012 Mar;18(3):409-17. doi: 10.1002/ibd.21793. Epub 2011 Jun 22.
- Background: PubMed 20534432Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Lozupone CA, Turnbaugh PJ, Fierer N, Knight R. Global patterns of 16S rRNA diversity at a depth of millions of sequences per sample. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4516-22. doi: 10.1073/pnas.1000080107. Epub 2010 Jun 3.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Uveitis
RecruitingObservational study
Ocular Fluid Work-up in Presumed Trematode Induced Granulomatous Uveitis
Presumed Trematode Induced Uveitis, Uveitis
Not yet recruitingObservational study
The Microbiome in Uveitis and Pediatric Inflammatory Diseases
Noninfectious Uveitis
RecruitingPhase 2
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of FXS5626 in Patients With NIU
Active Non-anterior, Non-infectious Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Y Chew, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is principal component analysis using the unweighted UniFrac distance metric of microbial composition; the significance between groups will be tested by the Adonis method (http://qiime.org/tutorials/category_comparison.html). (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859299, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.